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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K220813
Device Name ART-PLAN
Applicant
TheraPanacea
Pépinière Cochin Paris Santé, 29 rue du Faubourg
Saint-Jacques
Paris,  FR 75014
Applicant Contact Edwin Lindsay
Correspondent
TheraPanacea
Pépinière Cochin Paris Santé, 29 rue du Faubourg
Saint-Jacques
Paris,  FR 75014
Correspondent Contact Edwin Lindsay
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Codes
LLZ   MUJ  
Date Received03/21/2022
Decision Date 06/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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